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CLP

The new regulation 1272/08/EU

REACH

The regulation 1906/2006/EC

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Services

  • REACH
  • Enviroment Risk Assessment on pharmaceutical products
  • OELS determination and safety occupational classification
  • Toxicological Expertise
  • Single Study Monitoring
chemsafe

Single study monitoring

Small companies (SMEs) need sometime to commit experimental studies in order to complete the safety profile of a substance or of a preparation. In many cases small companies do not have skilled people to do this job and in particular who can spend time in finding the GLP laboratory, checking the quotation, monitor the study, evaluate the results and audit the draft reports.
Chemsafe, based again on its long lasting experience in experimental toxicology and ecotoxicology, can support such small companies in following the all the over-mentioned phases.
In particular we can offer:

  • Testing laboratory selection on the basis of the study to be performed.
  • All laboratories which are in the Chemsafe's network operates in compliance with GLP and have been inspected at least once for their quality in the facilities and for people operating (study directors, technicians, QAU, Archives etc)
  • Test item sample management (shipment to the testing labs)
  • Study plan signature on behalf od the sponsor. GLP sponsor is always the customer, Chemsafe appears only as Study Monitoring on behalf of...
  • In "vivo" phases monitoring
  • Evaluation of results and shipment to the customer with comment (i.e. possible classification, no problems, ect)
  • Study schedule
  • Study costs
  • Draft report audit
  • Final report shipment (two copies)
  • Invoicing at the final report delivery


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